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EC number: 203-347-8
CAS number: 105-95-3
In a reverse gene mutation assay performed
according to the OECD test guideline No. 471 and in compliance with GLP,
S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E.coli
strain WP2 uvrA were exposed to Ethylene Brassylate diluted in DMSO both
in the presence and absence of metabolic activation system (10% v/v S9
fraction in standard co-factors) using both the Ames plate incorporation
and pre-incubation methods, in triplicate. Concentrations of Ethylene
Brassylate up to, and including, 5000 µg/plate were tested. This is the
standard limit concentration recommended in the regulatory guidelines
that this assay follows. Other concentrations used were a series of ca
half-log10 dilutions of the highest concentration.
Evidence of weak toxicity, observed as a
slight reduction in revertant colony numbers, was obtained in the
Salmonella strains following exposure to the test material at 5000
µg/plate in the absence of S9 mix. No evidence of toxicity was obtained
in the E. coli strain, or in the presence of S9 mix.
No evidence of mutagenic activity was seen
at any concentration of Ethylene Brassylate in either mutation test.
The concurrent positive controls verified
the sensitivity of the assay and the metabolising activity of the liver
preparations. The mean revertant colony counts for the vehicle controls
were within or close to the current historical control range for the
Under the test condition, Ethylene Brassylate
is not mutagenic in the presence and absence of metabolic activation in
S. thyphimurium strains TA1535, TA1537 TA98 & TA100, and E.coli WP2 uvrA
according to the criteria of the Annex VI of the of the Regulation (EC)
No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
This study is considered as acceptable and
satisfies the requirement for reverse gene mutation endpoint.
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